U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER IX— TOBACCO PRODUCTS

21 U.S.C. § 387d

Submission of health information to the Secretary

Read at: OLRCuscode.house.gov CornellLII GovInfogovinfo.gov JustiaTitle 21 CasesGoogle Scholar
(a) RequirementEach tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary the following information:(1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.(2) A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accordance with regulations promulgated by the Secretary in accordance with section 1333(e) of title 15.(3) Beginning 3 years after June 22, 2009, a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 3 years after June 22, 2009, the manufacturer, importer, or agent shall comply with regulations promulgated under section 387o of this title in reporting information under this paragraph, where applicable.(4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.(b) Data submissionAt the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the following:(1) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents (including smoke constituents), ingredients, components, and additives.(2) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer.(3) Any or all documents (including underlying scientific or financial information) relating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors.An importer of a tobacco product not manufactured in the United States shall supply the information required of a tobacco product manufacturer under this subsection.(c) Time for submission(1) In general

At least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product not on the market on June 22, 2009, the manufacturer of such product shall provide the information required under subsection (a).

(2) Disclosure of additive

If at any time a tobacco product manufacturer adds to its tobacco products a new tobacco additive or increases the quantity of an existing tobacco additive, the manufacturer shall, except as provided in paragraph (3), at least 90 days prior to such action so advise the Secretary in writing.

(3) Disclosure of other actions

If at any time a tobacco product manufacturer eliminates or decreases an existing additive, or adds or increases an additive that has by regulation been designated by the Secretary as an additive that is not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use, the manufacturer shall within 60 days of such action so advise the Secretary in writing.

(d) Data list(1) In general

Not later than 3 years after June 22, 2009, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading to a lay person, and place on public display (in a manner determined by the Secretary) the list established under subsection (e).

(2) Consumer research

The Secretary shall conduct periodic consumer research to ensure that the list published under paragraph (1) is not misleading to lay persons. Not later than 5 years after June 22, 2009, the Secretary shall submit to the appropriate committees of Congress a report on the results of such research, together with recommendations on whether such publication should be continued or modified.

(e) Data collection

Not later than 24 months after June 22, 2009, the Secretary shall establish, and periodically revise as appropriate, a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand. The Secretary shall publish a public notice requesting the submission by interested persons of scientific and other information concerning the harmful and potentially harmful constituents in tobacco products and tobacco smoke.

(June 25, 1938, ch. 675, § 904, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1790.)Editorial NotesPrior Provisions

A prior section 904 of act June 25, 1938, was renumbered section 1004 and is classified to section 394 of this title.

Statutory Notes and Related SubsidiariesModification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

Notes of Decisions
Cited in 10 cases (2 in the last 5 years), 2010–2024 · leading case: Big Time Vapes, Inc. v. FDA, 963 F.3d 436 (5th Cir. 2020).
Sort: Relevance Newest Treatment
Big Time Vapes, Inc. v. FDA, 963 F.3d 436 (5th Cir. 2020). “See 21 U.S.C. § 387d(a). The Act also requires manufac- turers to file annual registration statements listing their products and to update those lists biannually.”
Nicopure Labs, LLC v. Food & Drug Admin., 266 F. Supp. 3d 360 (D.D.C. 2017). “They also cite 21 U.S.C. § 387d(a), which requires manufacturers to list “all ingredients ,.”
U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 703 F. Supp. 2d 329 (S.D.N.Y. 2010). “§ 387g(a)(4)(B)(v) (tobacco product standards, referencing Section 906(d), 21 U.S.C. § 387d); 21 U.S.C. § 387f(d) (1) (Section 906(d), sale and distribution includes restrictions on advertising).”
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). · cites it 23× “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024). · cites it 3× “Compare 21 U.S.C. § 387d(a) (listing the required contents of the 90-day report) with 21 C.”
Rozema v. U.S. Dep't of Health & Human Servs. (2d Cir. 2017). “See 21 U.S.C. §§ 387d(d), (e). Nor has Congress obligated the FDA 3 1 to add menthol to its harmful constituents list and disclose the data.”
Rozema v. United States Dep't of Health & Human Servs., 682 F. App'x 72 (2d Cir. 2017). “See 21 U.S.C. §§ 387d(d), (e). Nor has Congress obligated the FDA to add menthol to its harmful constituents list and disclose the data.”
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2023). “42 (a); and (2) a provision of the TCA applicable to the tobacco product manufacturers originally subject to the Act, see 21 U.S.C. § 387d(c)(1) (requiring manufacturers to submit information on their products “[a]t least 90 days prior” to introducing the products into…”
Am. Academy of Pediatrics v. Food & Drug Admin. (D. Maryland 2019). “at 9; 21 U.S.C. §§ 387d(j), 387j(b)(1), and the agency has issued a number of lengthy guidance documents discussing these statutory requirements: it issued final guidance concerning the SE process in January 2011, long before the deeming rule was finalized; three versions of a…”
Faircloth v. Food & Drug Admin. (S.D.W. Va 2017). “, 21 U.S.C. §§ 387d(a), 387a-1(a)(2)(G); Mem.”
— 21 U.S.C. § 387d(a) — 4 cases
Big Time Vapes, Inc. v. FDA, 963 F.3d 436 (5th Cir. 2020). “See 21 U.S.C. § 387d(a). The Act also requires manufac- turers to file annual registration statements listing their products and to update those lists biannually.”
Nicopure Labs, LLC v. Food & Drug Admin., 266 F. Supp. 3d 360 (D.D.C. 2017). “They also cite 21 U.S.C. § 387d(a), which requires manufacturers to list “all ingredients ,.”
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024). “Compare 21 U.S.C. § 387d(a) (listing the required contents of the 90-day report) with 21 C.”
Faircloth v. Food & Drug Admin. (S.D.W. Va 2017). “, 21 U.S.C. §§ 387d(a), 387a-1(a)(2)(G); Mem.”
— 21 U.S.C. § 387d(a)(1) — 1 case
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
— 21 U.S.C. § 387d(a)(3) — 1 case
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
— 21 U.S.C. § 387d(b) — 1 case
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
— 21 U.S.C. § 387d(b)(1) — 1 case
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
— 21 U.S.C. § 387d(c)(1) — 2 cases
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2023). “42 (a); and (2) a provision of the TCA applicable to the tobacco product manufacturers originally subject to the Act, see 21 U.S.C. § 387d(c)(1) (requiring manufacturers to submit information on their products “[a]t least 90 days prior” to introducing the products into…”
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024). “Compare 21 U.S.C. § 387d(a) (listing the required contents of the 90-day report) with 21 C.”
— 21 U.S.C. § 387d(d) — 2 cases
Rozema v. U.S. Dep't of Health & Human Servs. (2d Cir. 2017). “See 21 U.S.C. §§ 387d(d), (e). Nor has Congress obligated the FDA 3 1 to add menthol to its harmful constituents list and disclose the data.”
Rozema v. United States Dep't of Health & Human Servs., 682 F. App'x 72 (2d Cir. 2017). “See 21 U.S.C. §§ 387d(d), (e). Nor has Congress obligated the FDA to add menthol to its harmful constituents list and disclose the data.”
— 21 U.S.C. § 387d(d)(1) — 1 case
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
— 21 U.S.C. § 387d(d)(2) — 1 case
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
— 21 U.S.C. § 387d(d)(l) — 1 case
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
— 21 U.S.C. § 387d(e) — 1 case
Rozema v. U.S. Dep't of Health & Human Servs., 167 F. Supp. 3d 324 (N.D.N.Y. 2016). “• More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture.”
— 21 U.S.C. § 387d(j) — 1 case
Am. Academy of Pediatrics v. Food & Drug Admin. (D. Maryland 2019). “at 9; 21 U.S.C. §§ 387d(j), 387j(b)(1), and the agency has issued a number of lengthy guidance documents discussing these statutory requirements: it issued final guidance concerning the SE process in January 2011, long before the deeming rule was finalized; three versions of a…”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.